Informations générales (source: ClinicalTrials.gov)

NCT06236438 En recrutement IDF
A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (LIVIGNO-4)
Interventional
  • Carcinome pulmonaire non à petites cellules
  • Tumeurs du poumon
Phase 2/Phase 3
AbbVie (Voir sur ClinicalTrials)
avril 2024
octobre 2031
19 avril 2025
Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHI DE CRETEIL En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Diagnosis of histologically or cytologically confirmed metastatic nonsquamous
non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor
(EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for
which a locally approved targeted therapy is available.

- Must have at least 1 measurable lesion per response evaluation criteria in solid
tumors (RECIST) v1.1 as determined by the local site Investigator/radiology
assessment.

- Life expectancy of at least 3 months and adequate organ function.


- Received prior systemic therapy for the treatment of metastatic NSCLC.